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TRANSCATHETER AORTIC VALVE IMPLANTATION ..What is good and what is bad



An estimated 2% to 9% of the elderly have aortic stenosis.

 Aortic valve replacement reduces mortality rates and improves function in all age groups, including octogenarians. 

Those with asymptomatic aortic stenosis tend to decline very quickly once they develop heart failure, syncope, or angina. Aortic valve replacement has been shown to put people back on the course they were on before they became symptomatic.

Transcatheter self-expanding transaortic valve implantation was approved by the FDA in November 2011. The procedure does not require open surgery and involves angioplasty of the old valve, with the new valve being passed into place through a catheter and expanded. Access is either transfemoral or transapical.
Transaortic valve implantation has been rapidly adopted in Europe since 2002 without any randomized control trials. 

The Placement of Aortic Transcatheter Valves (PARTNER) trialin 2011 was the first randomized trial of this therapy. It was conducted at 25 centers, with nearly 700 patients with severe aortic stenosis randomized to undergo either transcatheter aortic valve replacement with a balloon-expandable valve (244 via the transfemoral and 104 via the transapical approach) or surgical replacement. The mean age of the patients was 84 years, and the Society of Thoracic Surgeons mean score was 12%, indicating high perioperative risk.

At 30 days after the procedure, 
the rates of death were 3.4% with transcatheter implantation and 6.5% with surgical replacement (P = .07). At 1 year, the rates were 24.2% and 26.8%, respectively (P = 0.44, and P = .001 for noninferiority). 

However, the rate of major stroke was higher in the transcatheter implantation group: 3.8% vs 2.1% in the surgical group (P = .20) at 1 month and 5.1% vs 2.4% (P = .07) at 1 year.
 Vascular complications were significantly more frequent in the transcatheter implantation group, and the new onset of atrial fibrillation and major bleeding were significantly higher in the surgical group.

Patients in the transcatheter implantation group had a significantly shorter length of stay in the intensive care unit and a shorter index hospitalization. At 30 days, the transcatheter group also had a significant improvement in New York Heart Association functional status and a better 6-minute walk performance, although at 1 year, these measures were similar between the two groups and were greatly improved over baseline. Quality of life, measured using the Kansas City Cardiomyopathy Questionnaire, was higher both at 6 months and at 1 year in the transcatheter implantation group compared with those who underwent the open surgical procedure.

 The higher risk of stroke with the transcatheter implantation procedure remains a concern. More evaluation is also needed with respect to function and cognition in the very elderly, and of efficacy and safety in higher- and lower-risk patients. Smith CR,Leon MB,Mack MJ,et al.PARTNER Trial Investigators.

 1- Transcatheter versus surgical aortic-valve replacement in high-risk patients.
N Engl J Med 2011; 364:2187–2198.
2-Health-related quality of life after transcatheter aortic valve replacement in inoperable patients with severe aortic stenosis. Circulation 2011; 124:1964–1972
                 
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